MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-06-26 for TEN20 CONDUCTIVE PASTE 10-20-XX manufactured by D. O. Weaver And Company.
[6260958]
Patient explained that she had a multiple sleep latency test (mslt) to confirm narcolepsy. The test occurred from 9:00 pm thursday (b)(6) ending at 4:00 pm friday (b)(6). That night or early the next day - saturday (b)(6), patient began to experience a severe skin irritation on her scalp, behind her ears, with the most severe areas being along the jawline which have spread toward her lips. The patient indicated that the scalp irritation and the rash behind her ears are nearly gone, but the rash spots described as "hive-like in appearance with small white pimples" remain on her face especially the jawline. Patient was advised to see her doctor immediately to prevent further spreading of the rash and to receive relief and appropriate treatment. Patient responded by saying she will "see if she can get in to see the doctor, probably not today, but maybe within the next day or so. " she did agree to phone back once she has seen her doctor to inform us of the prognosis.
Patient Sequence No: 1, Text Type: D, B5
[13524421]
Patient never called back like she said she would. We have attempted to contact her multiple times to ascertain her current status, but she has not returned our phone calls. If we receive any additional information, we will submit a follow-up report. We are aware that a very small percentage of the population may react negatively to topical products, likely due to hypersensitive skin and/or allergies. It is very rare that permanent scarring results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2015-00001 |
| MDR Report Key | 4871070 |
| Report Source | 04 |
| Date Received | 2015-06-26 |
| Date of Report | 2015-06-24 |
| Date of Event | 2015-05-22 |
| Date Mfgr Received | 2015-05-26 |
| Date Added to Maude | 2015-06-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. NICHOLAS LEE |
| Manufacturer Street | 565 NUCLA WAY, UNIT B |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal | 80011 |
| Manufacturer Phone | 3033661804 |
| Manufacturer G1 | D. O. WEAVER AND COMPANY |
| Manufacturer Street | 565 NUCLA WAY, UNIT B |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEN20 CONDUCTIVE PASTE |
| Generic Name | TEN20 |
| Product Code | GYB |
| Date Received | 2015-06-26 |
| Model Number | 10-20-XX |
| Catalog Number | 10-20-XX |
| Lot Number | UNK |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D. O. WEAVER AND COMPANY |
| Manufacturer Address | 565 NUCLA WAY, UNIT B AURORA CO 80011 US 80011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-06-26 |